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Clinical Diabetology (ISSN 2450–7458) is published six times a year by „Via Medica sp. z o.o.” sp.k.

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on the management of diabetic patients

A position of Diabetes Poland

The Writing Group:

dr hab. n. med. Aleksandra Araszkiewicz

Katedra i Klinika Chorób Wewnętrznych i Diabetologii, Uniwersytet Medyczny im. K. Marcinkowskiego w Poznaniu prof. dr hab. n. med. Elżbieta Bandurska-Stankiewicz Katedra Chorób Wewnętrznych, Uniwersytet Warmińsko-Mazurski w Olsztynie

prof. dr hab. n. med. Andrzej Budzyński II Katedra Chirurgii Ogólnej Collegium Medicum, Uniwersytet Jagielloński w Krakowie

prof. dr hab. n. med. Katarzyna Cypryk Klinika Diabetologii i Chorób Przemiany Materii, Uniwersytet Medyczny w Łodzi

prof. dr hab. n. med. Anna Czech

Katedra i Klinika Chorób Wewnętrznych i Diabetologii, II Wydział Lekarski, Warszawski Uniwersytet Medyczny prof. dr hab. n. med. Leszek Czupryniak Klinika Diabetologii i Chorób Wewnętrznych, Warszawski Uniwersytet Medyczny prof. dr hab. n. med. Józef Drzewoski Klinika Diabetologii, Chorób Wewnętrznych, Uniwersytet Medyczny w Łodzi

prof. dr hab. n. med. Grzegorz Dzida Katedra i Klinika Chorób Wewnętrznych, Uniwersytet Medyczny w Lublinie prof. dr hab. n. med. Tomasz Dziedzic Katedra Neurologii Collegium Medicum, Uniwersytet Jagielloński w Krakowie prof. dr hab. n. med. Edward Franek

Instytut Medycyny Doświadczalnej i Klinicznej im. M. Mossakowskiego, Polska Akademia Nauk,

Klinika Chorób Wewnętrznych, Endokrynologii i Diabetologii, Centralny Szpital Kliniczny MSW w Warszawie,

Warszawski Uniwersytet Medyczny dr inż. Danuta Gajewska

Katedra Dietetyki, Wydział Nauk o Żywieniu Człowieka i Konsumpcji SGGW w Warszawie

prof. dr hab. n. med. Maria Górska

Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych, Uniwersy- tet Medyczny w Białymstoku

prof. dr hab. n. med. Władysław Grzeszczak

Katedra i Klinika Chorób Wewnętrznych, Diabetologii i Nefrologii, Śląski Uniwersytet Medyczny

prof. dr hab. n. med. Janusz Gumprecht

Katedra i Klinika Chorób Wewnętrznych, Diabetologii i Nefrologii, Śląski Uniwersytet Medyczny

prof. dr hab. n. med. Barbara Idzior-Waluś

Katedra i Klinika Chorób Metabolicznych Collegium Medicum, Uniwersytet Jagielloński w Krakowie

prof. dr hab. n. med. Przemysława Jarosz-Chobot

Klinika Diabetologii Dziecięcej WLK, Śląski Uniwersytet Medyczny prof. dr hab. n. med. Zbigniew Kalarus

Katedra Kardiologii, Wrodzonych Wad Serca i Elektroterapii, Śląski Uniwersytet Medyczny, Śląskie Centrum Chorób Serca w Zabrzu prof. dr hab. med. Tomasz Klupa

Katedra i Klinika Chorób Metabolicznych Collegium Medicum, Uniwersytet Jagielloński w Krakowie

dr n. med. Teresa Koblik

Katedra i Klinika Chorób Metabolicznych Collegium Medicum, Uniwersytet Jagielloński w Krakowie

prof. dr hab. n. med. Andrzej Kokoszka

II Klinika Psychiatryczna, Warszawski Uniwersytet Medyczny prof. dr n. med. Anna Korzon-Burakowska

Katedra Nadciśnienia Tętniczego i Diabetologii, Gdański Uniwersytet Medyczny

prof. dr hab. n. med. Irina Kowalska

Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych, Uniwersytet Medyczny w Białymstoku

prof. dr hab. n. med. Adam Krętowski

Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych, Uniwersytet Medyczny w Białymstoku

prof. dr hab. n. med. Lilianna Majkowska Klinika Diabetologii i Chorób Wewnętrznych, Pomorski Uniwersytet Medyczny w Szczecinie prof. dr hab. n. med. Maciej Małecki

Katedra i Klinika Chorób Metabolicznych Collegium Medicum, Uniwersytet Jagielloński w Krakowie

prof. dr hab. n. med. Artur Mamcarz

III Klinika Chorób Wewnętrznych i Kardiologii, II Wydział Lekarski, Warszawski Uniwersytet Medyczny

prof. dr hab. n. med. Barbara Mirkiewicz-Sieradzka Klinika Chorób Metabolicznych, Szpital Uniwersytecki w Krakowie prof. dr hab. n. med. Wojciech Młynarski

Klinika Pediatrii, Onkologii, Hematologii i Diabetologii, Uniwersytet Medyczny w Łodzi

prof. dr hab. n. med. Dariusz Moczulski Klinika Chorób Wewnętrznych i Nefrodiabetologii, Uniwersytet Medyczny w Łodzi

prof. dr hab. n. med. Małgorzata Myśliwiec Katedra i Klinika Pediatrii, Diabetologii i Endokrynologii, Gdański Uniwersytet Medyczny

prof. dr hab. n. med. Krzysztof Narkiewicz Katedra Nadciśnienia Tętniczego i Diabetologii, Gdański Uniwersytet Medyczny

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Chapter 27 was developed in collaboration with Andrzej Marcinkiewicz, MD, and Prof. Jolanta Walusiak-Skorupa from the Institute of Occupational Medicine in Łódź, and Appendix 6 was developed in collaboration with Andrzej Gawrecki, MD.

Conflict of interest declaration of the Working Group members is available on the website: cukrzyca.info.pl Zespół Oddziałów Chorób Wewnętrznych, Diabetologii i Endokrynologii

II Wydziału Lekarskiego, Warszawski Uniwersytet Medyczny prof. dr hab. n. med. Joanna Rymaszewska

Zakład Psychiatrii Konsultacyjnej i Badań Neurobiologicznych, Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu prof. dr hab. n. med. Jacek Sieradzki

Katedra i Klinika Chorób Metabolicznych Collegium Medicum, Uniwersytet Jagielloński w Krakowie

prof. dr hab. n. med. Bogdan Solnica

Zakład Diagnostyki Collegium Medicum, Uniwersytet Jagielloński w Krakowie

prof. dr hab. n. med. Marek Strączkowski

Instytut Rozrodu Zwierząt i Badań Żywności Polskiej Akademii Nauk w Olsztynie

Zakład Chorób Metabolicznych, Uniwersytet Medyczny w Białymstoku

prof. dr hab. n. med. Krzysztof Strojek

Oddział Kliniczny Chorób Wewnętrznych Diabetologii i Schorzeń Kardiometabolicznych w Zabrzu,

Śląskie Centrum Chorób Serca, Śląski Uniwersytet Medyczny dr hab. n. med. Agnieszka Szadkowska

Klinika Pediatrii, Onkologii, Hematologii i Diabetologii, Uniwersytet Medyczny w Łodzi

Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych, Uniwersytecki Szpital Kliniczny w Białymstoku

prof. dr hab. n. med. Ewa Wender-Ożegowska Klinika Rozrodczości, Katedra Ginekologii,

Położnictwa i Onkologii Ginekologicznej, Uniwersytet Medyczny im. K. Marcinkowskiego w Poznaniu

prof. dr hab. n. med. Bogna Wierusz-Wysocka Szpital Miejski im. F. Raszei w Poznaniu dr n. med. Bogumił Wolnik

Uniwersyteckie Centrum Kliniczne, Gdański Uniwersytet Medyczny prof. dr hab. n. med. Mariusz Wyleżoł

Wojskowy Instytut Medycyny Lotniczej w Warszawie prof. dr hab. n. med. Edward Wylęgała Kliniczny Oddział Okulistyki, Wydział Lekarski z Oddziałem Lekarsko-Dentystycznym w Zabrzu, Śląski Uniwersytet Medyczny

prof. dr hab. n. med. Dorota Zozulińska-Ziółkiewicz Katedra i Klinika Chorób Wewnętrznych i Diabetologii, Uniwersytet Medyczny im. K. Marcinkowskiego w Poznaniu

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Table of Contents

The 2017 Diabetes Poland guidelines — remaining on the path of progress ... A1 1. Diagnostic criteria for dysglycemia... A5 2. Preventing and delaying development of diabetes ... A7 3. Blood glucose monitoring ... A8 4. Setting therapeutic targets in diabetes ... A9 5. Organization of care for adult patients with diabetes ... A10 6. Behavioral therapy (lifestyle changes) ... A12 7. Psychological management in diabetes ... A16 8. Education ... A17 9. General principles of the management of diabetes type 1 ... A19 10. Oral antidiabetic agents and GLP-1 receptor agonists in the management of diabetes type 2 ... A20 11. Insulin therapy ... A23 12. Treatment of hypertension in diabetic patients ... A24 13. Treatment of dyslipidemia ... A26 14. Hypoglycemia ... A29 15. Management of acute diabetes complications due to hyperglycemia ... A30 16. Diagnosis and management of ischemic heart disease in diabetic patients ... A32 16.1. Management of acute coronary syndromes in diabetic patients — glucose-lowering therapy ... A34 17. Stroke in diabetic patients ... A35 18. Prevention, diagnosis, and treatment of diabetic kidney disease ... A36 19. Diabetic eye disease ... A38 20. Prevention, diagnosis, and management of diabetic neuropathy ... A41 21. Diagnosis and management of diabetic foot syndrome ... A42 22. Diabetes in children and adolescents ... A45 23. Diabetes and pregnancy ... A51 24. Diabetes in the elderly ... A54

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27. Recommendations regarding professional activity of diabetic patients... A58 28. Diabetes care in penitentiary institutions ... A60 29. Metabolic surgery ... A60 30. Selected special situations in diabetic patients ... A61 Appendix 1. Recommendations regarding transition of patients with diabetes type 1

from pediatric to adult diabetes care ... A63 Appendix 2. Medical review and opining in drivers with dysglycemia or diabetes ... A65 Appendix 3. Charter of Employer and Employee Rights and Duties ... A69 Appendix 4. Recommendations of the Polish Endocrine Society and Diabetes Poland

on screening for thyroid dysfunction in diabetes type 1 and 2 ... A71 Appendix 5. Position of the Polish Society of Obesity Research and Diabetes Poland

on the use of low-calorie sweeteners ... A72 Appendix 6. Recommendations on personal insulin pump treatment reimbursed

by the National Health Fund in diabetic children, adolescents,

and young adults below 26 years of age ... A74

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The 2017 Diabetes Poland guidelines

— remaining on the path of progress

Since 2005, the Diabetes Poland (PTD, Polskie Towarzystwo Diabetologiczne) prepares and publishes annually its guidelines on the management of diabetic patients. The idea of guideline development was first suggested in 2004 by Prof. Jacek Sieradzki who was the president of PTD at that time. The first chairperson of the PTD Guideline Writing Group was Prof. Władysław Grzeszczak who acted in this capacity in 2005–2011, followed by the next president of PTD, Prof. Leszek Czupryniak, in 2011–2015.

The guidelines are a product of a team of nearly 50 experts representing numerous medical specialties, co- vering all aspects of clinical diabetes care. Guideline chapters were prepared by teams coordinated by their leaders.

The goal of this expert teamwork is to improve prevention, diagnosis, and management of diabetes and its complications in Poland. The PTD guidelines reflect advances in diabetology, including new clinical and experimen- tal study findings, epidemiological observations, and registry data. Thus, some modifications and novel aspects appear every year. However, as the guidelines have always been based on the principles of evidence-based medi- cine, only minor changes are required, related to new knowledge from reliable research with major implications for clinical practice.

In line with the principles of evidence-based medicine, levels of evidence underlying the recommendations have been introduced in some chapters of the 2017 PTD guidelines, similarly to the American Diabetes Association (ADA) guidelines.

Summary of the most important changes to the 2017 PTD guidelines

In Chapter 1, the contents has been rearranged and the approach to the diagnosis of hyperglycemia has been simplified. If no symptoms of hyperglycemia are present and random venous blood glucose is ≥ 200 mg/dL (11.1 mmol/L), fasting venous blood glucose ≥ 126 mg/dL (≥ 7.0 mmol/L) on one and not two occasions is now sufficient for the diagnosis of diabetes.

In Chapter 3 on glycemia monitoring, new information has been added regarding flash glucose monito ring (FGM).

In Chapter 4 on the treatment goals, the target HbA1c level in women with prepregnancy diabetes contempla- ting pregnancy has been set more liberally at < 6.5% (48 mmol/mol), in accordance with the opinion of other diabetes societies (ADA, National Institute for Health and Care Excellence — NICE), while HbA1c level < 6.0%

(42 mmol/mol) remains the goal in the second and third trimester, if it is not associated with an increased rate of hypoglycemia. Recommendation on target lipid levels have been expanded based on the available evidence. The treatment goal in diabetic subjects at very high cardiovascular risk is low-density lipoprotein cholesterol (LDL-C) level < 70 mg/dL (1.9 mmol/L) or reduction by at least 50% if baseline LDL-C level is 70–135 mg/dL (1.9–3.5 mmol/L), and LDL-C level < 100 mg/dL (2.6 mmol/L) or reduction by at least 50% if baseline LDL-C level is 100–200 mg/dL (2.6–5.2 mmol/L) in diabetic subjects at high cardiovascular risk. In subjects at low or moderate cardiova- scular risk, defined as subjects < 40 years of age with diabetes type 1 but without chronic complications and other cardiovascular risk factors), the goal LDL-C level is < 115 mg/dL (3.0 mmol/L). A secondary goal for lipid-lowering treatment is non-high-density lipoprotein cholesterol (non-HDL-C) level, also set in relation to the overall cardio- vascular risk at < 100 mg/dL (2.6 mmol/L) in diabetic subjects at very high cardiovascular risk, < 130 mg/dL (3.4 mmol/L) in sub jects at high cardiovascular risk, and at < 145 mg/dL (3.7 mmol/L) in subjects at low to mode- rate cardiovascular risk.

In Chapter 5 on the organization of care for patients with diabetes, recommendations have been added regarding care for patients with diabetic foot syndrome. This care should be provided by referral diabetes foot clinics (one per voivodship) and basic care clinics (the number depending on the population of given voivodship) that cooperate with referral clinics. Personnel requirements were set, as were the principles of multispecialty care, equipment requirements, access to laboratory and microbiological testing, and opportunities for hospital care.

In Chapter 6, multiple small editorial changes have been made, and the nomenclature has been improved.

The need for individualized nutrition care has been highlighted. Recommendations regarding carbohydrate and protein intake have been clarified. Carbohydrates should provide about 45% of the total calorie intake; and if they are consumed in the form of low glycemic index and high fiber content products, their share in the total calorie intake may be even higher (up to 60%). High caloric intake from carbohydrates should also be a feature of the diet in subjects who are very active physically. In contrast, a lower carbohydrate share in the total calorie intake

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(25–45%) may be temporarily recommended in patients with little physical activity if it cannot be significantly increased, e.g., due to concomitant conditions. In most diabetic patients, proteins should provide 15–20% of the total calorie intake (about 1–1.5 g/kg body weight/day). In patients with diabetes type 2 and excessive body weight, a low-calorie diet may contain 20–30% of protein. In patients with chronic kidney disease, protein intake should be about 0.8–1 g/kg body weight/day. Salt intake from all sources should not exceed 5 g per day.

In Chapter 8, recommendations regarding education have been updated, reflecting, among others, the techno- logical progress in blood glucose monitoring.

In Chapter 9 on the management of diabetes type 1, use of insulin analogs for insulin therapy has been pre- ferred based on the robust available evidence.

In Chapter 10, data from large randomized clinical trials have been included that indicate a reduction of total and cardiovascular mortality with the use of GLP-1 agonists and SGLT-2 inhibitors. The algorithm for drug treat- ment of diabetes type 2 has also been modified, with expanded options of insulin therapy intensification.

In Chapter 11, recommendations on initiating insulin therapy regardless of blood glucose levels have been clarified, which apply to all autoimmune-mediated diabetes types regardless of age and not only LADA, and not all but only warranted patient wishes. When glycemic control is reevaluated, insulin doses should be gradually increased by 2–4 units and not 4–8 units as recommended previously. In patients treated with single basal insulin injection, intensification of insulin therapy has been recommended when the basal insulin dose exceeds 30 units per day (10 units less compared to the previously recommended threshold). The recommended approaches to treatment intensification include adding rapid-acting insulin before meals, with possible stepwise intensification using the basal-plus approach, or alternatively initiation of mixed insulin therapy. A recommendation has been delated regarding insulin therapy using three or more insulin injections per day if the daily insulin requirement exceeds 80 units.

In Chapter 13 on the approach to treatment of dyslipidemia in 2016, the target LDL-C level < 70 mg/dL has been set for all patients with diabetes type 2. The target LDL-C level < 100 mg/dL has been only left in young pa- tients with diabetes type 1 without other cardiovascular risk factors. New clinical trial results and metaanalyses of these studies have resulted in updated European Society of Cardiology (ESC) recommendations on the treatment of dyslipidemia that have also been adopted by PTD. With the perceived need for more treatment individualization in diabetic patients, target LDL-C and non-HDL-C levels set in the 2017 PTD guidelines vary, primarily in relation to the 10-year cardiovascular mortality risk. This risk is defined as very high in diabetes with concomitant cardio- vascular disease (previous myocardial infarction, acute coronary syndrome, coronary revascularization or other revascularization procedures, stroke, transient ischemic attack, aortic aneurysm, and peripheral arterial disease) or other cardiovascular risk factors, i.e. albuminuria, hypertension, hypercholesterolemia, smoking, or a family history of cardiovascular disease. Patients without chronic diabetes complications and other cardiovascular risk factors are at high cardiovascular risk. Only in young patients with diabetes type 1 without chronic diabetes complications and other cardiovascular risk factors, the risk is moderate or low. Depending on the risk category, target LDL-C and non-HDL-C levels in the very high, high, and moderate to low risk groups are < 70 mg/dL and < 100 mg/dL,

< 100 mg/dL and < 130 mg/dL, and < 115 mg/dL and < 145 mg/dL, respectively. In this way, we hope to increase implementation of these guidelines in the clinical practice.

In Chapter 14, it has been highlighted in the section on the management of a prolonged hypoglycemic episode that this situation may occur with all diabetes types and not only in diabetes type 2.

In Chapter 15, data have been updated on the mortality due to diabetic ketoacidosis which is now estimated at 0.2–2%, and not 5% as indicated previously, and depends on such factors as the expertise of the treating team.

Recurrent episodes of diabetic ketoacidosis are associated with a much higher mortality risk. Regarding the diag- nosis of diabetic ketoacidosis, a comment has been added that in patients treated with SGLT-2 inhibitors, blood glucose values may be lower than the definition given (> 250 mg/dL). As commercial hypotonic 0.45% saline solution is now available, it has again been recommended in the treatment of hyperglycemic-hyperosmolar state.

In Chapter 21 on the organization of care for patients with diabetes foot syndrome, the organizational struc- ture of referral diabetes foot clinics (previously regional multi-specialty diabetes foot clinics) and basic care clinics (previously diabetes foot service in diabetology clinics) has been described, aiming to improve the diagnosis and treatment of diabetes foot syndrome in Poland. The recommendation regarding diagnostic tests for osteitis has been clarified, and the interval between follow-up foot X-rays has been defined as every 3 to 6 weeks.

Numerous editorial corrections have been made in Chapter 22. Target blood pressure values have been defined as < 130/85 mm Hg in those aged 16 years or above, while percentile charts remain in use in younger age groups.

When discussing insulin therapy, a recommendation has been added that the magnitude of the basal dose and

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its profile should depend on the age of the child and the type of insulin pump. Recommendations regarding in- sulin injections with meals have been clarified, and it has been indicated that in the youngest children, in whom planning the timing and size of the meal is not possible, dose splitting may be considered by administering half of the dose before a meal and the other half during or after a meal. Additions and modifications related to con- tinuous glucose monitoring have been added to the recommendations regarding blood glucose self-monitoring.

Important changes have been made to the Table 22.1 on the recommended intervals between serum lipid profile, albuminuria, serum creatinine, urinalysis, and thyroid function tests, as performance of these tests is now recom- mended every 1–2 years at the discretion of the treating physician.

In Chapter 23, significant changes have been made regarding the target 1-hour post-prandial blood glucose self-monitoring value which has been relaxed from 120 to 140 mg/dL. The target HbA1c level in the first trimester in women with prepregnancy diabetes has been specified at < 6.5% (48 mmol/mol). Nutritional recommendations have been amended, including the recommended protein intake of 1.3 g/kg of body weight, and the recommen- ded saturated fatty acid intake of less than 10% of the total energy value of the diet. Due to the fact that oral glucose-lowering agents pass through the placenta and no studies are available regarding their long-term effects in the offspring, no recommendation for metformin use during pregnancy has been upheld.

In Chapter 25, recommendations regarding glucose, insulin, and potassium infusion in adult diabetic patients in the perioperative period have been unified and simplified, and a section on differences regarding the mana- gement of children has been added.

A new Chapter 30 has been added to the 2017 PTD guidelines, with brief recommendations regarding selected special situations in diabetic patients, including shift work, time zone change, and glucocorticosteroid therapy.

In Appendix 4, errors regarding the management of diabetes type 1 in relation to the TPOAb titer have been corrected.

In Appendix 6 which includes recommendations regarding the principles of personal insulin pump therapy reimbursed by the National Health Fund in children, adolescents, and young adults below 26 years of age, the requirements for centers contracting this service have been clarified, which include patient education regarding continuous subcutaneous insulin infusion, providing the patient with an insulin pump, and offering consultation services. In case of insulin pumps with continuous glucose monitoring option, alarm presetting is recommended, taking into account the current level of metabolic control and patient capabilities. Patient knowledge should be verified using a diabetes knowledge test developed by PTD. The HbA1c level criterion for insulin pump therapy reimbursement has been changed from > 9.0% to ≥ 9.0%.

By making the above changes, in part suggested by the users of these recommendations, the 2017 PTD Guide- line Writing Group hopes that these guidelines will serve as an even better signpost leading to improved medical care for diabetic patients in our country.

We sincerely thank everybody who has contributed to the development of the new edition of PTD guidelines!

Prof. Dorota Zozulińska-Ziółkiewicz Prof. Maciej Małecki

Deputy President of the Diabetes Poland President of the Diabetes Poland Plenipotentiary of the Board

of the Diabetes Poland for Clinical Guidelines

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Table 1. American Diabetes Association evidence-grading system for “Standards of Medical Care in Diabetes”

Level of evidence Description

A Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including:

• Evidence from a well-conducted multicentre trial

• Evidence from a meta-analysis that incorporated quality ratings in the analysis

Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence- -Based Medicine at the University of Oxford

Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including:

• Evidence from a well-conducted trial at one or more institutions

• Evidence from a meta-analysis that incorporated quality ratings in the analysis B Supportive evidence from well-conducted cohort studies

• Evidence from a well-conducted prospective cohort study or registry

• Evidence from a meta-analysis of cohort studies

Supportive evidence from well-conducted case-control study C Supportive evidence from poorly or incontrolled studies

• Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results

• Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls)

• Evidence from case series or case reports

Conflicting evidence with the weight of evidence supporting the recommendation

E Expert consensus or clinical experience

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Table 1.1. Diagnostic criteria for dysglycemia Random blood glucose — measured in a blood sample collected at any time of the day, regardless of the timing of the last meal

Fasting blood glucose — measured in a blood sample collected 8–14 hours after the last meal

Blood glucose at 120 minutes during an oral glucose tolerance test (OGTT) according to WHO

Venous plasma glucose level

≥ 200 mg/dL (≥ 11.1 mmol/L) Æ diabetes*

(if symptoms of hyperglycemia are present, such as increased thirst, polyuria, fatigue)

70–99 mg/dL (3.9–5.5 mmol/L) Æ normal glucose tolerance (NGT)

100–125 mg/dL (5.6–6.9 mmol/L) Æ im- paired fasting glucose (IFG)

≥ 126 mg/dL (≥ 7.0 mmol/L) Æ diabetes*

< 140 mg/dL (7.8 mmol/L) Æ normal glu- cose tolerance (NGT)

140–199 mg/dL (7.8–11.0 mmol/L) Æ im- paired glucose tolerance (IGT)

≥ 200 mg/dL (≥ 11.1 mmol/L) Æ diabetes*

WHO — World Health Organization

*Diagnosis of diabetes requires one abnormal reading except for fasting blood glucose which requires two abnormal readings. A potential effect of factors not related to testing itself should be taken into account when measuring blood glucose (timing of the last meal, exercise, time of the day)

1. Diagnostic criteria for dysglycemia

Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia due to defective se- cretion and/or action of insulin. Chronic hypergly- cemia is associated with damage, dysfunction, and failure of various organs, in particular eyes, kidneys, nerves, heart, and blood vessels.

I. Symptoms suggesting the presence of diabetes:

— Body weight reduction;

— Increased thirst;

— Polyuria;

— Fatigue and somnolence;

— Presence of purulent skin lesions and inflamma- tory conditions of the genitourinary tract.

In case of the onset of symptoms random venous plasma glucose level should be measured (table 1.1).

II. Diagnostic criteria for dysglycemia (table 1.1):

— Random venous plasma glucose level measurement at the time when symptoms of hyperglycemia are identified — values ≥ 200 mg/dL (≥ 11.1 mmol/L) are consistent with the diagnosis of diabetes;

— If no symptoms are present or when symptoms are present and random blood glucose is < 200 mg/dL (< 11.1 mmol/L), fasting blood glucose should be measured twice on separate days — diabetes is diagnosed if fasting blood glucose on both these occasions is ≥ 126 mg/dL (≥ 7.0 mmol/L);

— If no symptoms of hyperglycemia are pre- sent and random blood glucose is ≥ 200 mg/dL (≥  11.1  mmol/L), fasting blood glucose should be measured and diabetes is diagnosed if fasting blood glucose is ≥ 126 mg/dL (≥ 7.0 mmol/L);

— An oral glucose tolerance test (OGTT) should be performed if fasting blood glucose on one or two occasions is 100–125 mg/dL (5.6–6.9 mmol/L), or impaired glucose tolerance (IGT) or diabetes may be reasonably suspected with fasting blood glu- cose < 100 mg/dL (< 5.6 mmol/L);

— An OGTT should be performed without prior limi- tations of carbohydrate intake in a fasting, rest-

ed subject after an overnight sleep; the subject should remain resting at the site of testing for the 2-hour period before ingestion of 75 g glucose so- lution and blood sampling, with all blood glucose level measurements performed in venous blood plasma in a laboratory;

— If OGTT is to be performed in a subject with pre- diabetes treated with metformin for that reason, the drug should be withdrawn at least one week before OGGT;

— OGTT is the preferred method to diagnose IGT.

Glucose meter measurements should not be used for diagnostic purposes.

Currently, PTD does not recommend measuring hae- moglobin A1c (HbA1c) level to diagnose diabetes.

III. Nomenclature of hyperglycemic states according to the World Health Organization (WHO):

— Normal fasting blood glucose: 70–99 mg/dL (3.9–

–5.5 mmol/L);

— Impaired fasting glucose (IFG): 100–125 mg/dL (5.6–6.9 mmol/L);

— Impaired glucose tolerance (IGT): 120-minute blood glucose at 120 minutes of OGTT 140–199 mg/dL (7.8–11 mmol/L);

— Prediabetes: IFG and/or IGT;

— Diabetes — one of the following criteria:

1. Symptoms of hyperglycemia and random blood glucose level ≥ 200 mg/dL (≥ 11.1 mmol/L);

2. Fasting blood glucose ≥ 126 mg/dL (≥ 7.0 mmol/L) on two occasions;

3. Blood glucose at 120 minutes of OGTT ≥ 200 mg/dL (≥ 11.1 mmol/L).

IV. Subjects at risk require screening for diabetes, as symptoms of hyperglycemia are absent in more than half of them. Testing for diabetes should be performed every three years in all subjects > 45 years of age. In addition, the following risk groups

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should be tested annually regardless of age:

— Overweight or obese subjects [body mass index (BMI) ≥ 25 kg/m2 and/or waist circumference > 80 cm (women) or > 94 cm (men)];

— Subjects with a family history of diabetes (in par- ents or siblings);

— Physically inactive subjects;

— Members of community or ethnic groups charac- terized by increased rates of diabetes;

— Those with prediabetes identified during previous testing;

— Women with a history of gestational diabetes;

— Women who gave birth to an infant with a birth weight > 4 kg;

— Subjects with hypertension (≥ 140/90 mm Hg);

— Subjects with dyslipidemia [high-density lipopro- tein (HDL) cholesterol < 40 mg/dL (< 1.0 mmol/L) and/or triglycerides > 150 mg/dL (> 1.7 mmol/L)];

— Women with polycystic ovary syndrome;

— Subjects with cardiovascular disease.

V. Etiologic classification of diabetes according to WHO:

1. Diabetes type 1

— Autoimmune;

— Idiopathic.

2. Diabetes type 2

3. Other specific forms of diabetes

— Genetic defects of beta cell function;

— Genetic defects of insulin function;

— Exocrine pancreatic diseases;

— Endocrinopathies;

— Drugs and chemicals;

— Infections;

— Rare immunologic forms of diabetes;

— Other genetic syndromes associated with diabetes.

4. Gestational diabetes

Latent autoimmune diabetes in adults (LADA) The category of autoimmune diabetes type 1 in- cludes slowly progressing diabetes caused by autoag- gression. Latent autoimmune diabetes in adults (LADA) is a late manifesting autoimmune form of diabetes in adults, most commonly diagnosed in patients above 35 years of age, characterized by clinical insulin inde- pendence in the first months after the diagnosis, with the presence of serum antibodies against glutamic acid decarboxylase (anti-GAD65) and/or other anti-islet antibodies and a low serum peptide C level. LADA is a form of diabetes type 1 with slowly progressive auto- immune-mediated destruction of beta cells. This diabetes subtype is present in 5–10% of subjects with diabe- tes diagnosed after 35 years of age and categorized as diabetes type 2. Clinical manifestations of LADA do not

always allow a definite diagnosis, presenting diagnostic challenges when differentiating with diabetes type 2.

A definite diagnosis of LADA requires identification of autoantibodies typical for diabetes type 1, mostly anti- GAD65, and/or a low serum peptide C level.

Monogenic diabetes

Monogenic diabetes amounts to 1–2% of all diabe- tes cases. It is caused by single gene mutations. Most forms are associated with a defect of insulin secretion, and the most common ones are maturity-onset diabe- tes of the young (MODY), mitochondrial diabetes, and neonatal diabetes. Taking into account the monogenic forms in the differential diagnosis of diabetes may con- tribute to treatment optimization and proper evaluation of prognosis in the patient and his family members.

A definite diagnosis of monogenic diabetes is a result of genetic testing. Patient selection for genetic testing for monogenic diabetes and any therapeutic decisions re- sulting from such a diagnosis should be made in centers with a large experience in this area.

Neonatal diabetes is defined as the disease onset before 9 months of age. Genetic testing should be per- formed in all patients with persistent neonatal diabetes.

This should include testing for mutations in the KCNJ11 gene which codes for Kir6.2 protein. Mutations in this gene are the most common cause of persistent neonatal diabetes. Regardless of age, most patients with KCNJ11 gene mutations may be treated with sulphonylureas which are effective and safe in this group and thus may be used as an alternative to insulin. Further targets for genetic testing include mutation in the insulin genes, the ABCC8 gene coding for SUR1 protein, ad the glucokinase gene. If a mutation in the ABCC8 gene is identified, sulphonylurea treatment may be attempted. Carriers of mutations in the insulin gene and a double mutation in the glucokinase gene need to be treated with insulin.

Decisions regarding search for mutations in other genes should be made individually by diabetes specialists (dia- betologists) with an appropriate experience in the genet- ics of diabetes.

In families with an autosomal dominant early-onset diabetes caused by impaired insulin secretion, in most cases without obesity, the differential diagnosis should include MODY and mutations in the responsible genes should be searched for. The most common form of MODY is associ- ated with HNF1A and glucokinase gene mutations.

Typical clinical presentation of MODY due to a HNF1A gene mutation includes:

1. Early onset of diabetes (typically before 25 years of age);

2. No insulin dependence and ketoacidosis, low insulin requirement, detectable peptide C levels despite the disease being present for several years or even longer;

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3. Family history of diabetes over at least 2 generations, with an early-onset diabetes in at least two family members. OGTT performed at an early stage of dia- betes usually shows high postprandial glucose level elevation with often normal fasting blood glucose;

4. Absence of autoantibodies typical for diabetes type 1;

5. Glycosuria higher than expected based on blood glu- cose levels.

Chronic complications of diabetes develop in a large proportion of patients with MODY due to a HNF1A gene mutation, and thus optimal disease control should be actively pursued early after the disease onset. Sulphonyl- ureas are the drugs of choice (except for pregnancy or the presence of typical contraindications to these drugs).

If these are not effective, combined therapy with insulin, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitors, or insulin monotherapy should be considered.

Testing for glucokinase gene mutations is indicated in the following situations:

1. Persistently elevated fasting blood glucose in the range of 99–144 mg/dL (5.5–8.0 mmol/L);

2. An increase in blood glucose during OGTT lower than 83 mg/dL (4.6 mmol/L);

3. A family history of diabetes in one of the parents, but negative family history does not exclude this form of diabetes.

Healthy nutrition with elimination of simple sugars is the treatment of choice in glucokinase defects due to a single gene mutation; drugs are usually ineffective.

HbA1c value characteristic for glucokinase defect is not higher than 7.5%.

Decisions regarding testing for mutations in other genes associated with MODY should be made individu- ally in centers experienced in such testing.

The most common cause of mitochondrial diabetes is the A3243G mutation of the gene coding for leucine tRNA.

Testing for this mutation should be performed in case of maternal transmission of an early-onset diabetes associated with deafness in some family members. The therapeutic approach in mitochondrial diabetes may include diet and treatment with sulphonylureas or insulin depending on the degree of defective insulin secretion. Metformin use should be avoided in mitochondrial diabetes.

Cystic fibrosis-related diabetes (CFRD)

Diabetes is present in about 20% of adolescents and 40–

–50% adults with cystic fibrosis, Diabetes associated with cystic fibrosis is classified as other specific type of diabetes associated with exocrine pancreatic disease, characterized by a slow progression and usually remains asymptomatic for many years. Diabetic ketoacidosis occurs rarely, most likely due to preserved endogenous insulin secretion or concomitant impairment of glucagon secretion. Initially, hyperglycemia is usually seen in circumstances that ex- acerbate insulin resistance, such as acute and chronic infections, glucocorticoid therapy, and ingestion of large amounts of carbohydrates (intake by oral or intravenous route, gastric tube or percutaneous gastrostomy).

Insulin therapy is the treatment of choice.

Routine annual testing for diabetes should be per- formed in generally healthy subjects with cystic fibrosis aged ≥ 10 years.

2. Preventing and delaying development of diabetes

Diabetes type 1

Currently, no effective and clinically useful methods exist to prevent diabetes type 1 both in the general popu- lations and in subjects at risk.

Diabetes type 2

Screening should be undertaken with fasting blood glucose measurements or OGTT using 75 g of glucose (see Chapter 1). It is also possible to use HbA1c level mea- surements to screen for dysglycemia.

I. Risk factors for diabetes type 2 (see Chapter 1).

II. Overview of recommendations regarding preven- tion and delaying development of diabetes:

— Subjects at a high risk of developing diabetes type 2 should receive appropriate education regarding

healthy lifestyle (health benefits related to moder- ate weight reduction and regular physical activity);

— Indications for screening (see Chapter 1);

— Patients with prediabetes (IFG or IGT) should be advised to reduce weight and increase physical activity. Pharmacological prevention of diabetes by using metformin should be considered in sub- jects at a high risk of developing diabetes type 2, particularly if IFG or IGT is present;

— Repeated advice regarding lifestyle changes is of paramount importance for the effectiveness of prevention;

— It is recommended to monitor patients for other cardiovascular disease risk factors (e.g., tobacco smoking, hypertension, dyslipidemia) and their treatment;

— Use of diabetogenic drugs should be avoided.

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Table 3.1. Recommended frequency of blood glucose self-monitoring

Treatment regimen Frequency of blood glucose self-monitoring

Multiple (i.e., at least 3 times daily) insulin injections Intensive insulin therapy, regardless of the diabetes type

Multiple (i.e., at least 4 times daily) readings during the day according to the treatment regimen and patient needs

Diet treatment only 4-point blood glucose profile (fasting and 2 hours post main

meals) once a month, once a week at various times of the day Oral hypoglycemic drugs and/or GLP analogs 4-point blood glucose profile (fasting and 2 hours post main

meals) once a week, once daily at various times of the day Diabetes type 2 treated with fixed insulin doses 1–2 readings daily plus 4-point blood glucose profile (fasting and

2 hours post main meals) once a week plus 7-point blood glucose profile once a month

All patients Additional immediate readings in case of feeling unwell, sudden

illness etc.

GLP — glucagon-like peptide

Current monitoring and retrospective evaluation of blood glucose levels are integral parts of adequate diabe- tes treatment. Appropriate blood glucose self-monitoring (BGSM) requires regular patient education in this regard, including evaluation of the ability to use glucose meter and interpret BGSM results, i.e. using them for day-to- day modification of nutrition, exercise, and medication doses. Regular HbA1c level measurements are another necessary component of diabetes treatment monitoring.

I. Blood glucose self-monitoring

Blood glucose self-monitoring is an integral part of diabetes treatment.

Patients treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) should perform a daily blood glucose profile that includes read- ings at morning fast, before and 60–120 minutes after each main meal, and before bedtime. Frequency and timing of additional measurements should be set indi- vidually.

Use of blood glucose monitoring systems including continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) to supplement blood glucose self- monitoring is particularly indicated in patients with labile diabetes type 1 with frequent hypoglycemia episodes and hypoglycemia unawareness, as it improves treatment safety and effectiveness.

Blood glucose self-monitoring is also indicated to reach therapeutic targets in patients treated with single insulin injections, oral antidiabetic agents, diet, and pre- scribed physical exercise (Table 3.1).

Proper BGSM requires patient education regarding glucose meter use, interpretation of readings, and fur- ther management steps. For BGSM, it is recommended to use glucose meters that display plasma glucose level

with the declared margin of error of up to 15% for glu- cose levels ≥ 100 mg/dL (5.6 mmol/L) and 15 mg/dL (0.8 mmol/l) for glucose levels < 100 mg/dL (5.6 mmol/L).

Analysis of glucose readings using a computer software may be useful in patients performing ≥ 4 measurements daily. Glucose meters and the technique of their use by the patients should be checked in case of suspected mea- surement errors and at least once a year at the facility where the patient receives outpatient treatment.

II. Hemoglobin A1c (HbA1c)

Hemoglobin A1c level reflects average blood glucose levels during the period of approximately 3 last months, with about 50% of HbA1c currently present in blood being formed during the last month before the measurement.

Hemoglobin A1c level measurements should be per- formed annually in patients with stable disease in whom the therapeutic targets have been met. In those in whom the therapeutic targets have not been met or the treat- ment has been modified, HbA1c level should be measured at least every 3 months.

Hemoglobin A1c level measurements should be per- formed using analytic methods certified by the Nation- al Glycohemoglobin Standardization Program (NGSP) (http://www.ngsp.org). Point-of-care testing for HbA1c is also possible when using methods and analyzers certified by NGSP.

It has been suggested that diagnostic laboratories report HbA1c levels in SI units (mmol/mol) in addition to traditional units.

When interpreting HbA1c levels, interfering factors should be taken into account, such as changes in the erythrocyte survival time, hemoglobinopathies, and chemical hemoglobin modifications which may render use of these measurements difficult or impossible.

3. Blood glucose monitoring

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I. General considerations

1. Therapeutic targets in diabetes include target blood glucose levels, blood pressure values, lipid profile, and body weight.

2. In older patients and those with comorbidities, who are expected to survive for less than 10 years, thera- peutic targets should be relaxed so as to not compro- mise patient’s quality of life.

3. Generally, therapeutic targets and treatment intensifi- cation should be largely individualized. In all diabetic patients, and particularly those with diabetes type 2, the following factors should be taken into account when setting therapeutic targets: patient’s attitude towards treatment and the expected engagement in the treatment process (including that of patient’s family members, caretakers etc.), the risk of hypogly- cemia and its possible consequences (more severe in the elderly, and in those with preexisting cardiovascu- lar or nervous system damage), duration of diabetes, expected survival, presence of major vascular diabetic complications and significant comorbidities, the de- gree of patient’s education, and the risk-to-benefit ratio associated with specific therapeutic targets. In some circumstances (e.g., in those with advanced complications and in the elderly), the therapeutic

targets should be attained gradually, within several (2 to 6) months.

II. Criteria of adequate blood glucose control (ta- king into account the above considerations) A general target:

HbA1c ≤ 7% (≤ 53 mmol/mol) Individual targets:

a) HbA1c ≤ 6.5% (≤ 48 mmol/mol)

— Diabetes type 1 [fasting and preprandial blood glucose, including BGSM: 80–110 mg/dL (4.4–

–6.1 mmol/L); 2-hour post-prandial BGSM <

140 mg/dL (7.8 mmol/L)];

— Diabetes type 2 of a short duration;

— In children and adolescents, regardless of the diabetes type. When evaluating blood glucose profile in relation to target HbA1c, values gi- ven in Table 4.1 should be consulted, showing mean daily blood glucose values and blood glucose ranges corresponding to specific HbA1c

levels.

b) HbA1c ≤ 8.0% (≤ 64 mmol/mol)

— In patients at an advanced age and/or in dia- betics with macroangiopathic complications

Table 4.1. Relation between HbA1c levels and average plasma glucose levels

HbA1c Average plasma

glucose levels Average fasting

blood glucose Average preprandial

blood glucose Average postprandial blood glucose

[mg/dL] [mmol/L] [mg/dL] [mg/dL] [mg/dL]

6 126 7.0

< 6.5 122 118 144

6.5–6.99 142 139 164

7 154 8.6

7.0–7.49 152 152 176

7.5–7.99 167 155 189

8 183 10.2

8–8.5 178 179 206

9 212 11.8

10 240 13.4

11 269 14.9

12 298 16.5

Correlation between HbA1c and average plasma glucose levels 0.92 (according to Diabetes Care 2015; 28: 35)

4. Setting therapeutic targets in diabetes

Most important recommendations

• In diabetic patients, the overall goal of diabetes control is HbA1c

level ≤

7.0% (53 mmol/mol). [A]

• In all patients with diabetes type 1 and increased urinary albumin secretion and/or renal dysfunction, a statin is recommended to reduce LDL-C level by at least 50% regardless of the baseline LDL-C level. [C]

• In patients with diabetes type 2 and cardiovascular disease or chronic kidney disease, and those > 40 years of age without overt cardiovascular disease but with ≥ 1 risk factor or target organ damage, lipid-lowering therapy is recommended to reach the goal LDL-C level of < 70 mg/dL (1.8 mmol/L). [B]

• In patients with diabetes type 2 without target organ damage and risk factors, the goal LDL-C level is < 100 mg/dL (2.6 mmol/L). [B]

• The recommended blood pressure goal is < 140/90 mm Hg. [A]

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(previous myocardial infarction and/or stroke) and/or multiple comorbidities;

c) HbA1c level < 6.5% (48 mmol/mol) in women with prepregnancy diabetes contemplating pregnancy,

< 6.0 % (42 mmol/mol) in the second and third trimester, if it is not associated with an increased rate of hypoglycemia.

If a diabetic patient aged > 65 years is expected to survive for more than 10 years, gradual attainment of general therapeutic targets should be aimed for, with target HbA1c level ≤ 7%.

Correlation between HbA1c and average plasma glucose levels 0.92 (according to Diabetes Care 2015;

28: 35)

III. Criteria of adequate lipid profile control:

— LDL-C level < 70 mg/dL (1.9 mmol/L) or reduction by at least 50% if baseline LDL-C level is 70–135 mg/dL (1.9–3.5 mmol/L) in diabetic subjects at very high cardiovascular risk;

— LDL-C level < 100 mg/dL (2.6 mmol/L) or reduction by at least 50% if baseline LDL-C level is 100–200

Comprehensive diabetes care requires input of ade- quately competent physicians, nurses or educators enga- ged in diabetic education, and dietitians. Care should be patient-centered, taking into account individual patient situation, needs, and preferences. Due to multidiscipli- nary nature of late diabetic complications and conco- mitant conditions, cooperation with other specialists is also necessary.

Children and adolescents and pregnant women — see relevant chapters.

I. Outpatient care

Modern diabetes treatment requires competencies regarding treatment, monitoring, and patient educa- tion to convey appropriate knowledge and motivation to comply with treatment recommendations. Cooperation between primary care physicians and specialists is also required.

II. Goals of primary care

1. Promoting healthy lifestyle to prevent development of dysglycemia.

2. Identification of risk factors for diabetes.

3. Investigating diabetes and prediabetes.

4. Evaluation of the risk of long-term complications.

5. Investigating early stages of long-term complications.

6. Managing patients with diabetes type 2 treated with li- festyle changes (diet, physical activity), and oral agents.

mg/dL (2.6–5.2 mmol/L) in diabetic subjects at high cardiovascular risk;

— LDL-C level < 115 mg/dl (3.0 mmol/L) in subjects at low or moderate cardiovascular risk (subjects < 40 years of age with diabetes type 1 but without chronic complications and other cardiovascular risk factors);

— Non-HDL cholesterol level < 100 mg/dL (2.6 mmol/L) in diabetic subjects at very high cardiovascular risk;

— Non-HDL cholesterol level < 130 mg/dL (3.4 mmol/L) in diabetic subjects at high cardiovascular risk;

— Non-HDL cholesterol level < 145 mg/dL (3.7 mmol/L) in subjects < 40 years of age with diabe- tes type 1 but without vascular complications or other cardiovascular risk factors;

— Triglyceride level < 150 mg/dL (< 1.7 mmol/L);

— HDL cholesterol > 40 mg/dL (> 1.0 mmol/L) [in women, higher by 10 mg/dL (0.275 mmol/L)].

IV. Criteria of adequate blood pressure control:

— Systolic blood pressure < 140 mm Hg;

— Diastolic blood pressure < 90 mm Hg.

Details — see Chapter 12.

5. Organization of care for adult patients with diabetes

7. Initiation and continuation of insulin therapy combi- ned with oral agents in patients with diabetes type 2.

8. Referring treated patients (at least once a year) for specialist consultations to:

— Evaluate metabolic control;

— Evaluate the severity of long-term complications and initiate specific treatment if needed;

— Provide education regarding lifestyle changes;

— Set therapeutic targets and treatment plans.

III. Goals of specialist care (Table 5.1)

1. Evaluation of treatment effects and setting therapeu- tic targets during annual specialist check-ups in dia- betic patients managed by primary care physicians.

2. Managing patients with diabetes type 1 and other ty- pes of diabetes treated with injected agents [insulin, glucagon-like peptide 1 (GLP-1) receptor agonists].

3. Performing specialist investigations and the differen- tial diagnosis of diabetes types, including diagnosis and treatment of monogenic diabetes and diabetes combined with other diseases.

4. Investigating, monitoring, and preventing progres- sion of long-term complications.

5. Diabetes education.

6. Investigating and managing diabetes in pregnant women (in collaboration with obstetricians).

7. Managing patients with clinically overt complications.

8. Investigating concomitant conditions.

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Table 5.1. Recommendations regarding monitoring in adult diabetic patients

Parameter Comments

Nutritional and therapeutic education At each visit

HbA1c Once a year, more frequently if doubts regarding maintenance of

normoglycemia or need to verify treatment effectiveness following its modifications

Serum total cholesterol, HDL cholesterol, LDL cholesterol,

triglycerides Once a year, more frequently if dyslipidemia

Albuminuria Once a year in patients not receiving an angiotensin-converting

enzyme inhibitor or an angiotensin receptor blocker

Urinalysis (with urine sediment) Once a year

Serum creatinine + estimation of eGFR Once a year (beginning at 5 years after the diagnosis in diabetes type 1)

Serum creatinine, Na+, K+, Ca2+, PO43– Every six months in patients with elevated serum creatinine Fundoscopy (with mydriasis) At 5 years after the diagnosis in diabetes type 1, at the time of the

diagnosis in diabetes type 2 (details see Chapter 19) eGFR — estimated glomerular filtration rate; HbA1c — hemoglobin A1c; HDL — high-density lipoprotein; LDL — low-density lipoprotein

IV. Goals of specialist inpatient care

1. Cases of newly detected diabetes type 1 and diabetes type 2 with symptomatic hyperglycemia.

2. Acute diabetic complications (hypo- and hyperglyce- mia, diabetic ketosis and coma).

3. Exacerbation of chronic complications.

4. Performance of minor procedures.

5. Modifications of the treatment regimen in patients in whom therapeutic targets cannot be met during outpatient therapy.

6. Initiation of intensive insulin therapy using a personal insulin pump and/or continuous glucose monitoring system (cgms).

7. Initiation of insulin therapy in gestational diabetes and preexisting diabetes previously not treated with insulin.

8. Difficulties with obtaining normoglycemia in pre- gnant patients with preexisting diabetes.

V. Organizational requirements Specialist diabetes hospital units

A. Physician personnel — two full-time diabetologists (in pediatric units, two diabetologists or pediatric endocrinologists and diabetologists), alternatively, in addition to a diabetologist, an internist (pediatri- cian in pediatric units) or endocrinologist with an experience in diabetology confirmed by the diabetes voivodship consultant.

B. Nursing staff — two nurses with an experience in education, with duties limited to education and care for diabetic patients, a diabetes educator if possible.

C. Dietician — with duties limited to diabetes care (at least half-time).

D. Access to specialist consultations (as in diabetes clinics, including psychologist consultations).

Recommended therapeutic team staffing for eve- ry 15–20 adult diabetes beds: 2–3 physicians, 2 nurses experienced in care for diabetic patients, a dietician, a psychologist (employed or available as a consul- tant), and a social worker.

E. Equipment:

— At least one intensive metabolic care bed per 10 regular diabetes beds;

— Space and necessary teaching equipment for edu- cation (education room);

— Required equipment: medical scales, blood pres- sure monitors, intravenous infusion pumps, glucose meters, food scales, neurological hammers, 128 Hz tuning forks, monofilaments, and continuous ac- cess to cardiac [exercise testing, electrocardiograp- hy (ECG), ECG Holter monitoring, ambulatory blood pressure monitoring, coronary angiography] and vascular (Doppler ultrasonography) investigations.

— Recommended (optional) equipment: continuo- us subcutaneous glucose monitoring system, op- hthalmoscope, pedobarography, neurothesiome- ter, Doppler cine-loop.

Specialist diabetes clinics

A. Physician personnel — a diabetologist (in pedia- tric diabetology clinic, a diabetologist or pediatric endocrinologist and diabetologist) and another phy- sician: an internist, pediatrician, or endocrinologist with an experience in diabetology confirmed by the diabetes voivodship consultant.

B. Nursing staff — a nurse with at least one year pro- fessional experience in diabetes nursing, with formal duties limited to care for diabetic patients, a diabetes educator if possible.

C. Dietician — with duties limited to diabetes care (at least half-time).

D. Psychologist — employed or available as a consultant.

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E. Access to specialist consultations, including servi- ces of a(n):

— Ophthalmologist;

— Nephrologist;

— Neurologist;

— Vascular surgeon or angiology specialist;

— Cardiologist;

— Orthopedic surgeon.

F. Social worker

A therapeutic team that includes one physician, one nurse experienced in diabetic nursing, one dietician (part- -time) and a psychologist may provide care to 800 adult diabetic patients.

Children and adolescents, pregnant women — see relevant chapters.

G. Equipment in specialist diabetes clinics:

— Required: medical scales, blood pressure monitors, glucose meters, 128 Hz tuning forks, monofila- ments, food scales;

— Recommended (optional): continuous subcutaneo- us glucose monitoring system, ambulatory blood pressure monitoring system, ophthalmoscope, neu- rothesiometer, computers with printers to retrieve and print glucose meter, personal insulin pump, and continuous glucose monitoring system data. Howe- ver, computer equipment that allows data retrieval from insulin pumps and continuous glucose moni- toring systems is necessary for the proper manage- ment of patients with diabetes type 1 treated with a personal insulin pump.

VI. Organization of care for patients with diabetic foot syndrome

A. Referral diabetes foot outpatients clinics 1. Personnel requirements:

Physicians: equivalent of at least 2 full-time positions

— diabetes specialist with at least one year of docu- mented experience in the management of patients with diabetic foot syndrome;

Nurses: equivalent of at least 2 full-time positions

— at least one year of documented experience in the management and care of patients with diabetic foot syndrome or chronic wounds.

2. An established organizational pathway allowing pa- tient hospitalizations in a unit within the same facility (medical center) that has a contract for diabetology or internal medicine services signed with the Polish Na- tional Health Fund (NFZ, Narodowy Fundusz Zdrowia).

3. Access to multidisciplinary care, including surgeon, vascular surgeon, or angiology specialist consulta- tions.

4. Ability to provide intravenous antibiotic therapy.

5. Access to basic imaging modalities, e.g. X-ray, ultra- sound (including Doppler studies) and CT and/or MRI.

6. Access to laboratory and microbiologic testing perfor- med in a medical diagnostic laboratory listed in the re- gister of the National Chamber of Laboratory Diagnosti- cians (KRDL, Krajowa Rada Diagnostów Laboratoryjnych).

B. Basic care outpatients clinics

1. The responsibility of these clinics should include the diagnosis and management of diabetes foot syndro- me along with prevention of ulcerations, infections, and Charcot neuro-osteoarthropathy complicating diabetes foot syndrome. These clinics should coope- rate with referral clinics where more severe cases are consulted and offered further treatment.

6. Behavioral therapy (lifestyle changes)

Most important recommendations

• All diabetic patients should be offered education regarding the general principles of proper diabetes nutrition by appropriately trained personnel (physician, dietician, diabetes nurse, diabetes educator) and using various methods and techniques, including telemedicine. Detailed nutritional recommendations should be tailored to the needs and capabilities of the patient. [A]

• The major macronutrient determining periprandial insulin requirement are carbohydrates. Instruction how to estimate carbohydrate content of a meal to optimize insulin dosing should be a key component of dietary educa- tion in patients with diabetes type 1. [A]

• There is no single universal diet that would be appropriate for all diabetic patients. The optimal proportions of macronutrients for a given patient should be determined individually, taking into account patient’s age, physical activity, presence of diabetes complications, and concomitant conditions. [E]

• Due to its pleotropic benefits, physical exercise is an integral part of proper comprehensive diabetes management.

For optimal effects, exercise should be regular, undertaken at least every 2–3 days but preferably daily. [A]

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Duration of the initial education (i.e., at the time of the diagnosis) should be at least 5 hours in diabetic individuals treated with diet or diet and oral

In the section “Goals of specialist inpatient care”, in the points concerning: treatment of patients with newly diagnosed type 1 diabetes and type 2 diabetes with clinical symptoms

FreeStyle Libre system is FreeStyle LibreLink application which enables the caregivers to trace the patient’s blood glucose readings and support the patient in

• The recommended treatment approach is intensive insulin therapy using multiple subcutaneous insulin doses or continuous subcutaneous insulin infusion (CSII) using a personal

In acute coronary syndromes, normalization of blood glucose levels using intravenous insulin infusion is recom- mended in somewhat vague states of relative hypergly- cemia,

Celem pracy było porównanie czasu leczenia DKA u pacjentów z cukrzycą hospitalizowanych od początku w ośrodku referencyjnym, którym dla Wielkopolski jest Katedra i

In acute coronary syndromes, normalization of blood glucose levels using intravenous insulin infusion is rec- ommended in somewhat vague states of relative hy- perglycemia,